武田痛風藥爆出死亡風險, FDA 發佈痛風藥物的最強警告

2019年2月FDA發佈:與另一種痛風藥物別嘌醇相比,武田製藥痛風藥物Uloric的患者死亡風險增加。因此,FDA將更新Uloric的處方信息,增加一則黑框警告,同時增加一則新的患者用藥指南。

武田痛風藥爆出死亡風險, FDA 發佈痛風藥物的最強警告

National law firm Fears Nachawati is launching an immediate investigation into the popular gout drug Uloric, manufactured by Takeda Pharmaceuticals , after the U.S. Food and Drug Administration issued a boxed warning stemming from the increased risk of death from Uloric use.

美國國家法律公司 Fears Nachawati 正在對武田製藥公司生產的廣受歡迎的痛風藥物 Uloric 展開立即調查。此前,美國食品藥品監督管理局(FDA)發佈了一項由 Uloric 使用增加的死亡風險引起的盒裝警告。

On Feb. 21, 2019, the FDA concluded that there is an increased risk of death from Uloric (febuxostat) compared to another gout medicine, Zyloprim (allopurinol.) This conclusion is based on the FDA's in-depth review of results from a clinical safety study, which found a higher risk of heart-related deaths when taking Uloric.

2019年2月21日, FDA 得出結論,與另一種痛風藥物 Zyloptil相比, Uloric的死亡風險增加。這一結論是基於 FDA 對臨床安全性研究結果的深入審查,該研究發現服用 Uloric 時與心臟相關的死亡風險更高。

The FDA ordered a boxed warning be put on Uloric, as well as a new patient medication guide. The FDA is also limiting the approved use of Uloric to certain patients who either have an adverse reaction to allopurinol or for whom that drug has not been an effective treatment.

FDA 命令對 Uloric 進行盒裝警告,併發布新的病人用藥指南。FDA 還將批准的 Uloric 的使用限制在某些對別嘌醇有不良反應或該藥物尚未有效治療的病人身上。

The FDA approved Uloric in 2009 for the chronic management of hyperuricemia, which occurs when there is too much uric acid in the bloodstream. High uric acid levels can lead to several diseases, including gout, a painful type of arthritis.

FDA 在2009年批准了 Uloric 用於慢性高尿酸血癥的治療,當血液中尿酸過多時就會發生高尿酸血癥。高尿酸水平可能導致多種疾病,包括痛風,一種痛苦類型的關節炎。

In March 2018, it was announced that Uloric was inexplicably linked to more cardiac deaths than was allopurinol, the drug typically given to patients with gout and cardiovascular disease. Before that announcement, the FDA requested that Uloric be removed from the market in a drug recall in November 2017.

2018年3月,有消息稱, Uloric 與心臟病死亡人數之比超過別嘌醇,後者是典型的給予痛風和心血管疾病患者的藥物。在該公告之前, FDA 要求在2017年11月的藥品召回中將 Uloric 從市場上撤除。


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